Most basic protocol programs for cleanrooms are based on the Institute of Environmental Science and Technology (IEST) recommended practices for contamination control and the ISO 14644 series of international standards for cleanrooms and associated controlled environments. The focus of any protocol program is to protect the integrity of the cleanroom and the products and processes in the cleanroom from the people working in the cleanroom. Whereas contamination may be due to the product, processes, or equipment in the clean-room, the people working in the cleanroom exercise the greatest control over the cause of and elimination of contamination. Therefore, all protocol programs address the functionality of the cleanroom, the behavior of the people working in the cleanroom,and the cleaning and maintenance of the cleanroom.
The basic components of abalanced cleanroom protocol program are:
FACILITY DESIGN
Initially, one must understand the design, layout, and certification of the cleanroom. IEST-RP-CC012.2, “Considerations in Cleanroom Design” is an excellent document to reference for understanding the design and functions of various components in cleanrooms (i.e., air flow, room pressures and particle management, etc.). Appendix B, “Sample cleanroom construction protocol” provides protocol guidance to cleanroom construction employees during the four levelsof cleanroom construction. This IEST recommended practice supports ISO 14644-4, “Clean-roomsand associated controlled environments – Part 4: Design.” Since 1999,cleanrooms have been certified to ISO 14644-1, “Cleanrooms and associatedcontrolled environments – Part 1: Classification of air cleanliness” andISO 14644-2, “Cleanrooms and associated controlled environments – Part2: Specifications for testing and monitoring to prove compliance with ISO 14644-1.
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